Global Study Manager

AstraZeneca • Durham, NC

3d • Hybrid

About The Position

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The role Drive end-to-end delivery of global clinical studies. As a Global Study Manager (GSM), you’ll coordinate cross-functional work from Protocol development through set-up, maintenance, close-out, CSR, and archiving—delivering to time, cost, and quality. You’ll partner with the GSD/GSAD and internal/external teams to execute delegated study activities in line with the Delivery Model, AZ Project Management Framework, ICH-GCP, AZ SOPs, policies, and values.

Requirements

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• 2+ years experience in all phases of a clinical study lifecycle with relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Excellent knowledge of international guidelines ICH/GCP
• Excellent communication and relationship building skills, including external service provider management skills
• Good project management skills
• Demonstrated ability to collaborate as well as work independently, along with demonstrated leadership skills

Responsibilities

• Lead coordinated delivery: Oversee day-to-day study execution with AZ experts and external providers to meet timelines, budget, and quality targets.
• Shape study documentation: Draft/own delegated documents (e.g., ICFs, master Clinical Study Agreements) and vendor materials (specs, procedures, presentations).
• Orchestrate partners: Maintain productive relationships with CROs and other providers; plan and run key meetings (e.g., Investigator/Monitor meetings).
• Secure supplies: Liaise with Clinical Supply Chain and vendors to ensure uninterrupted IP and study material supply.
• Manage risk and issues: Proactively identify, mitigate, and track risks/actions; escalate with context and solutions.
• Ensure inspection readiness: Keep Trial Master File content complete, accurate, and quality-verified; adhere to processes and ICH-GCP at all times.
• Support financials: Assist with budget tracking and invoice reconciliation; contribute to transparent cost management.
• Govern outsourced delivery: Support oversight of CRO Project Managers and document oversight per AZ SOPs (e.g., services/TOO).
• Improve how we work: Lead or contribute to non-drug improvement projects to streamline processes and outcomes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees